Delving into the Latest Updates on Faes Farma SA with Synapse

Overview

Basic Info

Introduction

Faes Farma SA is a pharmaceutical corporation that specializes in the production and distribution of chemical and pharmaceutical goods. In addition to this, the company also engages in activities such as acquiring, purchasing, selling, investing, holding, managing, negotiating, and leasing various assets including companies, securities, patents, trademarks, and social participations. The company was established in 1933 and is headquartered in Leioa, Spain.

Tags

Otorhinolaryngologic Diseases

Immune System Diseases

Endocrinology and Metabolic Disease

Small molecule drug

Chemical drugs

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Endocrinology and Metabolic Disease	1
Infectious Diseases	1
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	2
Chemical drugs	1

Top 5 Target	Count

H1 receptor(Histamine H1 receptor)	1
VDR(Vitamin D receptor)	1

This is a multi-centre, randomised, double blind, placebo-controlled, parallel-group, phase III study to assess the safety, tolerability and efficacy of Bilastine ophthalmic solution 0.6% in children with a documented history of seasonal allergic conjunctivitis (SAC) or perennial allergic conjunctivitis (PAC).

Start Date26 Mar 2021

Sponsor / Collaborator

Faes Farma SA

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100 Clinical Results associated with Faes Farma SA

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0 Patents (Medical) associated with Faes Farma SA

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6

Literatures (Medical) associated with Faes Farma SA

01 Dec 2024·European Journal of Pharmaceutical Sciences

Comparative inhibition by oral bilastine, parenteral dexchlorpheniramine, and a new bilastine parenteral (i.v. and i.m.) formulation of histamine-induced wheal and flare response: A randomised phase I trial

Article

Author: Molina, Pol ; Gich, Ignasi ; Arranz, Paula ; Sánchez, Carlos ; Gilaberte, Inmaculada ; Puntes, Montserrat ; Coimbra, Jimena ; Antonijoan, Rosa

BACKGROUNDBilastine is a well-known non-sedating second-generation antihistamine authorised worldwide for the symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria with proven efficacy and good safety and tolerability profile. When the oral route is not suitable or a rapid onset of action is preferred, parenteral formulations represent an effective treatment option. However, the parenteral formulations currently available are sedating antihistamines. The objective of this research was to compare the peripheral anti-H₁ activity of different bilastine formulations (i.v., i.m. and oral) and dexchlorpheniramine among them also versus placebo.METHODSThis was a single-dose, randomized, crossover, double-blind, placebo-controlled, phase I clinical study performed on 25 adult healthy volunteers that compared the peripheral antihistaminic activity of a single dose of bilastine 12 mg i.v., bilastine 12 mg i.m., bilastine 20 mg oral tablets and dexchlorpheniramine 5 mg i.m. among them and versus placebo by inhibiting the histamine-induced wheal and flare (W&F) response. Pharmacokinetics, safety, and tolerability were also evaluated.RESULTSAll bilastine formulations showed a rapid onset of action (15 min for parenteral and 30 min for the oral formulation), and the maximum effect in both wheal (i.v. 74.44 %; i.m.:74.29 %; oral 70,27 %) and flare area reduction (i.v. and i.m. 80.63 %; oral 77.67 %), was significantly larger compared to dexchlorpheniramine i.m. (25.85 % for wheal and 28.65 % for flare) and placebo (1.35 % for wheal and 4.02 % for flare). A more pronounced reduction in itching score was reached for bilastine oral, followed by i.m. and i.v. formulations. No serious adverse events (SAEs) were reported during the study, and 8 treatment-emergent adverse events (TEAEs) were reported by 5 subjects, all resolved without sequelae. For psychomotor assessments, dexchlorpheniramine i.m. showed a fast onset of drowsiness, as well as decreased attention and coordination when compared to all bilastine formulations and placebo.CONCLUSIONSAll bilastine formulations showed a peripheral H₁-blocking effect inducing a significantly greater inhibition of the wheal and flare response as compared to dexchlorpheniramine i.m. or placebo and provided a greater reduction of the itching sensation score. This study reconfirmed that bilastine has no sedative effect, even in a parenteral formulation. These results suggest that new bilastine parenteral formulation (i.v. or i.m.) may represent a suitable alternative for patients requiring immediate treatment of histamine-mediated type I hypersensitivity reactions, such as acute urticaria, or in those cases where oral administration is not possible.

01 Jan 2022·International Archives of Allergy and Immunology

Lack of Clinical Relevance of Bilastine-Food Interaction in Healthy Volunteers: A Wheal and Flare Study

Article

Author: Martínez, Joan ; Puntes, Montserrat ; Coimbra, Jimena ; Molina, Pol ; Campo, Cristina ; Labeaga, Luis ; Antonijoan, Rosa ; Gich, Ignasi

Introduction: The aim of this study was to compare the pharmacodynamic activity of bilastine administered under fasting and fed conditions in healthy volunteers. Methods: In this randomized, open-label, two-period, crossover study involving 24 healthy subjects, once-daily oral bilastine 20 mg was administered for 4 days under fasting and fed conditions, with a 7-day washout period. Bilastine plasma concentrations were measured for 24 h after the first and fourth doses in each period. Pharmacodynamic activity was assessed by wheal and flare surface inhibition and subjective assessment of itching, after intradermal injection of histamine 5 μg. Results: When administered under fed versus fasting conditions, exposure to bilastine 20 mg decreased (mean maximum plasma concentration and area under the curve from time 0 to 24 h decreased by 34.27% and 32.72% [day 1], respectively, and 33.08% and 28.87% [day 4]). Despite this, the antihistaminic effect of bilastine 20 mg was not altered by food. On day 1, as assessed by wheal and flare surface inhibition, the maximum effect and duration of action of bilastine did not differ to a significant extent between fasting and fed conditions, with only a short 30-min delay in the onset of wheal inhibition. At steady state (day 4), bilastine’s pharmacodynamic effects were not significantly affected under fasting or fed conditions. Conclusion: The pharmacokinetic interaction of bilastine with food does not imply a significant reduction of its peripheral antihistaminic efficacy. Despite a slight delay in onset of action on the first treatment day, the global clinical efficacy of bilastine is not affected by coadministration with food.

02 Apr 2020·Journal of Dermatological TreatmentQ4 · MEDICINE

Efficacy and safety of bilastine in reducing pruritus in patients with chronic spontaneous urticaria and other skin diseases: an exploratory study

Q4 · MEDICINE

Article

Author: Novák, Zoltan ; Campo, Cristina ; Serra, Esther ; Majorek-Olechowska, Bernadetta ; García-Bea, Aintzane ; Pulka, Grazyna ; Labeaga, Luis

Purpose: To evaluate the efficacy/safety of bilastine in pruritus relief in patients with chronic spontaneous urticaria (CSU) or other pruritic skin diseases.Methods: In this multicenter, open-label, exploratory study (EudraCT No.: 2016-001505-17), 115 adults with CSU (n = 34), eczema/dermatitis (n = 30), prurigo (n = 25) or cutaneous pruritus (n = 26), received bilastine 20 mg once daily for 8 weeks, or in non-responder patients (<30% improvement in pruritus score at week 2), 40 mg/day from week 2.Results: The mean change in weekly pruritus severity score from baseline to week 8 (primary endpoint) was reduced with bilastine (overall and by disease group); overall, percentage and absolute reductions were 71.16% and 1.63 points, respectively (p < .001). Updosed non-responders (n = 31) had improved weekly pruritus severity scores from baseline to week 8; percentage and absolute reductions were 49.08% and 1.13 points, respectively (p < .001). Bilastine improved the Dermatology Life Quality Index at weeks 4 and 8 (p < .001) in all disease groups, and the 7-day Urticaria Activity Score in CSU patients (p < .001). Bilastine was well tolerated.Conclusions: Bilastine relieved pruritus associated with urticaria and other skin diseases, with a very good safety profile.

100 Deals associated with Faes Farma SA

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100 Translational Medicine associated with Faes Farma SA

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Pipeline

Pipeline Snapshot as of 26 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 3 Clinical

1

2

Approved

Other

7

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Bilastine ( H1 receptor )	Eczema More	Approved
Dosmalfate	Poisoning More	Approved
Calcifediol ( VDR )	Vitamin D Deficiency More	Phase 3 Clinical
Alinastine ( H1 receptor )	Conjunctivitis, Allergic More	Discontinued
Lerisetron ( 5-HT3 receptor )	Nausea More	Discontinued